PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) is an FDA 510(k)-cleared medical device (K984259) manufactured by Cl-Tinters. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 1999. Regulation: 8.